Kornimate/medical-research-clean huggingface dataset:
phase i interaction study of istaroxime and digoxin in subjects with stable heart failure

Conditions: Heart Failure

Summary: this study explores a potential drug-drug interaction between istaroxime and digoxin in patients with stable chf on chronic oral digoxin treatment.

this is a single center, randomized, double blind, placebo controlled, escalating dose phase i interaction study. the three dose levels of istaroxime or placebo will be randomized sequentially to three cohorts (i to iii) of 16 patients each (12 patients on istaroxime and 4 patients on placebo). digoxin will be administered non blinded in all patients, once daily in the morning after a standardized breakfast, continuing with previously personalized dosage schedule during the screening period, treatment period, post treatment period and follow up period. prior to accrual of cohorts ii and iii, a data monitoring committee (dmc) will advise on the continuation to the next istaroxime dose, based on a predetermined safety review. this 37 day study includes a screening period (days -21 to -1), a treatment period (day 1), a post treatment period (days 2-4), and a follow up period (which includes one patient visit on day 14). patients will be confined in the phase i research center from day -2 to day 4.

Eligibility criteria:
inclusion criteria: main screening inclusion criteria : * signed informed consent; * male or female patients ≥18 years; * female patients of childbearing potential must not be pregnant; * chronic stable cardiac function impairment (no change in heart failure medication over the last 3 months and without any dosage adjustment in the last 4 weeks); * systolic blood pressure (sbp) of ≥ 90 mmhg and ≤ 140 mmhg; * lvef ≤ 35% by any method (to be performed at screening if not measured within the last 12 months); * chronic treatment (i.e. once daily dosing without interruption) with oral digoxin started at least 3 months prior to study entry and without any concomitant administration of other positive inotropic drugs; exclusion criteria: main screening exclusion criteria : * need for current or intermittent intravenous positive inotrope administration within the preceding 6 months, or hemodynamic support devices; * acute coronary syndrome within the past 3 months; * coronary artery bypass graft or percutaneous coronary intervention within the past 3 months; * stroke within the past 6 months; * atrial fibrillation or uncontrolled heart rate (hr) (\> 100 beats per minute \[bpm\]); * significant arrhythmia or second or third degree atrio-ventricular block; * valvular disease as the primary cause of hf; * significant ecg abnormalities as assessed by appropriately qualified physician or investigator including qtcf \>450; * positive testing for human immunodeficiency virus (hiv), hepatitis b and/or hepatitis c; main randomization exclusion criteria: * hr \> 100 bpm or \< 50 bpm; * serum potassium \> 5.3 mmol/l or \ 1.1 mmol/l or \< 0.6 mmol/l, * tn i \> uln.

Keywords: digoxin inotropes lusitropic agents istaroxime debio 0614
the effect of effervescent alendronate on bone turnover

Conditions: Osteopenia or Osteoporosis

Summary: 64 postmenopausal women are randomized to treatment with either effervescent and buffered alendronate or conventional alendronate -both 70mg weekly for 16 weeks to see if bone turnover is suppressed to the same extent as in the conventional formulation with the effervescent form.

alendronate is mainstay in the treatment of osteoporosis but is often discontinued due to gastro-intestinal side-effects. these side effects are believed to be caused by a low gastric ph induced by the drug. effervescent and buffered alendronate is a new formulation that increases gastric ph and thereby decreases risk of side effects but the clinical effect of the drug is not fully elucidated. in the present study 64 postmenopausal women with a bone mineral density t-score \< -1 are randomized 1:1 to open label treatment with effervescent and buffered alendronate or conventional alendronate 70 mg weekly for 16 weeks. the primary end-point is change in the bone resorption marker "carboxy-terminal collagen crosslinks" from baseline to 16 weeks. the decrease in the two groups is compared using non-inferiority statistics. secondary end-points include change in the bone formation marker "propeptide of type 1 procollagen", rate of change in the two bone markers and occurence of side effects.

Eligibility criteria:
inclusion criteria: * 2 years since last menstrual bleeding * bone mineral density t-score \< -1 at either lumbar spine or hip * ctx \> 0.42 µg/l exclusion criteria: * ever treatment for osteoporosis * indication for teriparatide treatment * treatment with oral systemic glucocorticoids within last 12 months * rheumatoid arthritis * inflammatory bowel disease * untreated thyroid disease * primary hyperparathyroidism * diabetes mellitus * egfr \< 60 ml/min * cancer within last 2 years except basal cell carcinoma of the skin * hormone therapy * unstable liver disease * contraindications for alendronate * major gastrointestinal disease within 12 months (eg. esophagitis, ulcer, major surgery). * vitamin d \< 50nmol/l
a study to evaluate the abuse potential of eb-1020 immediate-release in healthy recreational stimulant users

Conditions: Healthy Volunteers; Drug Users

Summary: this single-center study will be a single-dose, randomized, double-blind, placebo- and active-controlled crossover study with a single inpatient treatment visit. the abuse potential of single oral doses of eb-1020 ir (400 mg, 800 mg) will be compared with that of placebo and d-amphetamine (20 mg, 40 mg; active control) in healthy recreational stimulant users. subjects will participate in a medical screening visit (visit 1), one 4-day inpatient qualification phase (visit 2), one 11-day inpatient treatment phase (visit 3), and a safety follow-up visit (visit 4).

subjects will be randomized to 1 of 10 treatment sequences according to a two 5 x 5 william squares design. to maintain blinding, subjects will be required to ingest eight capsules with approximately 240 ml water on each study drug administration day. serial pharmacodynamic (pd) evaluations will be conducted up to 24 hours after each study drug administration. pharmacokinetic (pk) samples will be obtained to confirm exposure to eb-1020. safety monitoring will include recording of adverse events (aes), regular assessments of vital signs measurements, 12-lead electrocardiogram (ecg) findings, and continuous telemetry monitoring for at least 3 hours after study drug administration.

Eligibility criteria:
inclusion criteria: 1. subjects must be healthy male nondependent recreational drug users 2. subjects must be 18 to 55 years old, inclusive. 3. subjects must have greater than or equal to 10 lifetime nontherapeutic experiences with central nervous system (cns) stimulants (e.g., amphetamines, cocaine, methylphenidate), greater than or equal to 1 nontherapeutic use of prescription stimulants within the 12 months prior to screening, and greater than or equal to 1 nontherapeutic use of a cns stimulant within the 12 weeks prior to screening. exclusion criteria: 1. subjects that are deemed medically unsuitable or unlikely to comply with the study protocol for any reason. 2. subjects who do not pass qualification phase criteria to be eligible for the treatment phase.

Keywords: abuse liability recreational drug user stimulant d-amphetamine adhd
pharmacokinetics of nebulized amikacin in patients with pneumonia undergoing mechanical ventilation

Conditions: Ventilator Associated Pneumonia

Summary: inclusion of patients undergoing mechanical ventilation and presenting a pneumonia in order to determine serum pharmacokinetics of nebulized amikacin. the primary aim is to determine the dose of amikacin to be nebulized in order to observe amikacin serum concentrations close to but inferior to those observed after standart intravenous amikacin infusion.

after inclusion, patients undergo intravenous infusion of 20 mg/kg of amikacin with amikacin serum concentrations being monitored over the following 24 hours. randomization occures after this first amikacin infusion. patients are randomized to group nebulized amikacin or intravenous amikacin. the three next days of the study patients recieve nebulized amikacin (or nebulized placebo) during mechanical ventilation and a placebo infusion (amikacin infusion in case of placebo nebulization) using a air driven jet nebulizer. amikacin serum concentrations are monitored over 24 hours after each nebulization. patients are followed up during 10 days for safety and efficacy. the dose of amikacin to be nebulized is 60 mg/kg for the first 6 patients (phase a), 80 mg/kg for the next 6 patients (phase b) and 100 mg/kg for the last 6 patients (phase c). each phase is started after review of the results of the preceeding phase by an idependent safety and monitoring board.

Eligibility criteria:
inclusion criteria: * patients admitted to intensive care unit. * patients undergoing mechanical ventilation for more than 48h. * suspicion of ventilator associated pneumonia. exclusion criteria: * allergy to amikacin or any compound of the medication. * body mass index \> 30 kg/m2. * myasthenia gravis. * acute or chronic renal failure. * vestibulo-cochlear disease. * pregnancy. * brain death.

Keywords: pneumonia nebulization amikacin
role of c-reactive protein /albumin ratio in evaluation of disease activity in patients with inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases

Summary: role of c-reactive protein /albumin ratio in evaluation of disease activity in patients with inflammatory bowel disease.

inflammatory bowel disease (ibd) is defined as a life long chronic inflammatory disease affecting the gastrointestinal tract resulting from the interaction of environmental and genetic elements, has been a global healthcare problem with a steadily increasing incide ibd is mainly composed of two different bowel-relapsing disorders, including crohn's disease (cd) and ulcerative colitis (uc). early detection of the disease activity of ibd is of great significance for the treatment of this disease, which can effectively prevent complications and therefore improve prognosis as well as quality of life. in current clinical practice, commonly used noninvasive biomarkers such as c-reactive protein (crp) and erythrocyte sedimentation rate (esr), are considered to be important for both early diagnosis and accurate monitoring of the disease activity in ibd patients. the c-reactive protein/albumin ratio (car) is indicative of the balance between inflammation and nutritional status, making it an excellent marker for assessing disease activity in patients the disease activity of uc and cd patients was evaluated by the mayo score and crohn disease activity inde (cdai).

Eligibility criteria:
inclusion criteria: * patients with ibd which included crohn disease and ulcertive colitis patients above age 18 years old. exclusion criteria: * concurrent infections, liver cirrhosis, hematological diseases, heart failure, malignancies, autoimmune diseases, or congenital or acquired immunodeficiencies
a phase 1 study of s-3304 in patients with solid tumors

Conditions: Solid Tumors

Summary: to determine the maximum tolerated dose and safety profile of s-3304 in patients with biopsy accessible cancer who have failed previous therapy or to whom no standard therapies are available. to determine the pharmacokinetic profile of s-3304 in this patient population


Eligibility criteria:
inclusion criteria: * biopsy proven diagnosis of solid tumor(s) with biopsy accessible lesion(s) * must be able to tolerate oral medication exclusion criteria * patients with other serious illnesses * patients who are receiving treatments

Keywords: neovascularization matrix metalloproteinases antiangiogenesis type iv collagenases
levosimendan in high risk heart valve surgery

Conditions: Heart Failure

Summary: prospective, randomized, double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery. study hypothesis: levosimendan diminishes the need for adrenergic inotropic drugs and morbidity and may improve survival after heart valve surgery.

200 patients are prospectively randomized in a double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery. levosimendan/placebo is administered as 24 hour continuous infusion beginning after anesthesia induction. primary endpoint being adrenergic inotrope need after cardiopulmonary bypass and secondary endpoints hospital and 6-month mortality and major organ failure.

Eligibility criteria:
inclusion criteria: eligible for cardiac valve or combined cabg and cardiac valve surgery: * clinical signs of cardiac insufficiency exclusion criteria: * endocarditis

Keywords: heart failure levosimendan cardiac surgery
acute caffeine ingestion on futsal performance

Conditions: Caffeine; Placebo

Summary: caffeine supplementation has been recognized such as an useful strategy for improving performance in intermittent sports, however caffeine ingestion in futsal has been barely studied. in this randomized placebo-controlled study, we investigated the effects of acute caffeine supplementation in improving neuromuscular performance and physical match activity in futsal players.

to date, no previous investigation has studied the effect of acute caffeine ingestion on futsal performance during futsal-specific testing and during a simulated match. therefore, the aim of this investigation was to establish the effects of acute caffeine intake on futsal-specific tests (e.g. futsal kicking velocity) and match-play running performance in male futsal players.

Eligibility criteria:
inclusion criteria: * sub-elite men futsal players exclusion criteria: * intolerance to caffeine, * suffering from any chronic pathology or an injury in the month prior to the investigation * use of medicines or dietary supplements during the study.
intra-operative use of indigo carmine dye for the delineation of ill defined tumor borders using stereotactic injection

Conditions: Brain Tumors With Ill-defined Margins

Summary: the purpose of this study is to investigate whether stereotactic indigo carmine injection can safely increase the extent of tumor resection.

low grade gliomas are brain tumors with usually poorly defined borders between tumor and normal brain. this characteristic of low grade gliomas makes the gross total resection of the tumor extremely difficult. nevertheless, several studies have demonstrated that the risk of recurrence and progression into a more malignant tumor can be decreased with a more aggressive surgical resection. an aggressive attempt to achieve a gross total resection may result in the resection of normal brain and therefore neurological injury. for this reason, the more common error is to subtotally resect the tumor leaving significant volumes of tumor behind. many techniques have been introduced to safely increase the extent of resection, since the extent of resection is associated with a higher survival rate. each one of these techniques has several shortcomings. the current study will assess whether the intraoperative stereotactic injection of the indigo carmine at the tumor margins helps to safely increase of extent of tumor resection. in the first step of the study the safety and the correlation between resection of stained tissue/extend of tumor resection will be assessed. if the results are satisfactory, then the second step will ensue. in the second step we will assess the utility of indigo carmine as an additional adjunct to guide tumor resection.

Eligibility criteria:
inclusion criteria: * subjects with gliomas or other tumors that may have ill defined margins during the operative resection. exclusion criteria: * subjects with a contraindication for brain mri scan. subjects who are pregnant, younger than 18 years old or have a contraindication for indigo carmine are excluded as well

Keywords: brain tumor resection indigo carmine dye
a study of aleglitazar in combination with metformin in patients with type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy

Conditions: Diabetes Mellitus Type 2

Summary: this multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of aleglitazar in combination with metformin in patients with type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. patients will be randomized to receive either aleglitazar 150 mcg orally daily or placebo for 26 weeks in combination with their pre-existing metformin regimen and dose.


Eligibility criteria:
inclusion criteria: * adult patient, \>/= 18 years of age * type 2 diabetes mellitus treated with stable metformin monotherapy for at least 12 weeks prior to screening; metformin dose should be \>/= 1500 mg/day (or individual maximum tolerated dose), but no more than the maximum dose specified in the label * hba1c \>/= 7% and \</= 9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit * fasting plasma glucose \</= 13.3 mmol/l (\</= 240 mg/dl) at pre-randomization visit * agreement to maintain diet and exercise habits implemented during the run-in phase during the full course of the study exclusion criteria: * pregnant women, women intending to become pregnant during the study period, currently lactating women, or women of child-bearing potential not using highly effective, medically approved birth control methods * diagnosis or history of: 1. type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes 2. acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months * any previous treatment with thiazolidinedione or with a dual ppar agonist * any body weight lowering or lipoprotein-modifying therapy (e.g. fibrates) within 12 weeks prior to screening with the exception of stable (\>= 1 month) statin therapy * prior intolerance to fibrate * treatment with anti-diabetic medication other than metformin in the last 12 weeks prior to screening * triglycerides (fasting) \> 4.5 mmol/l (\> 400 mg/dl) at screening or within 4 weeks prior to screening * clinically apparent liver disease * anemia at or within 4 weeks prior to screening * inadequate renal function * symptomatic congestive heart failure nyha class ii-iv at screening * myocardial infarction, acute coronary syndrome or transient ischemic attack/stroke within 6 months prior to screening visit * known macular edema at screening or prior to screening visit * diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years * uncontrolled hypertension * history of active substance abuse (including alcohol) within the past 2 years
withdrawal of etanercept after successful treatment of juvenile idiopathic arthritis

Conditions: Juvenile Idiopathic Arthritis

Summary: the purpose of this study is to determine whether etanercept can be withdrawn successfully (i.e. no occurrence of flares) in juvenile idiopathic arthritis (jia) patients in whom disease remission is reached. goals: 1. to investigate in a randomized controlled trial: * which proportion of jia patients in remission can successfully discontinue etanercept compared to jia patients in remission who continue etanercept; * if time in remission on etanercept is an important factor in retaining remission after discontinuation of etanercept. 2. to investigate in alle jia patients who discontinue etanercept (including the control group): * predicting factors (patient or disease characteristics, including time in remission, and mrp8/mrp14) for successfully discontinuation of etanercept; * the disease course after discontinuation of etanercept (time to flare) and the effect of restarting etanercept after flaring.

juvenile idiopathic arthritis (jia) is the most common cause of chronic arthritis in children. etanercept has proven to be an effective treatment for jia. considering the risk of occurrence of long-term side-effects and to prevent the burden of the weekly injections and costs, it is a logical step to discontinue etanercept after reaching remission (no disease activity for at least six months). especially since there are concerns about the long-term effect of suppressing the immune system with etanercept. however, little is known about if successful discontinuation is possible or when to stop. risk is that the disease might flare (reactivate) again. for this study, jia patients in remission will be selected from the abc-register (an observational study including all dutch jia patients who use etanercept). eligible patients will be randomized to stop etanercept or continue it for another 9 months. patients are followed with standard visits evaluating disease activity until 12 months after discontinuation of etanercept. in case of a disease flare etanercept therapy will be reintroduced immediately and the patient will be treated according to the insight of their treating physician. expected is that jia patients who were in remission for more than 12 months before discontinuation have a better chance to retain remission.

Eligibility criteria:
inclusion criteria: * diagnosis of juvenile idiopathic arthritis (all subtypes) by the international league of associations of rheumatology (ilar) criteria * on etanercept therapy * no mtx or low dose mtx (maximum 10 mg/m2) * 3 or more months in remission according to the criteria of wallace (i.e. 9 or more months of inactive disease) * age ≥4 and \<18 years at start of study * written informed consent from parents and patients 12 years and over exclusion criteria: * systemic corticosteroids (up to 9 months prior to inclusion) * intra-articular corticosteroids (up to 6 months prior to inclusion) * synthetic dmards besides low dose mtx (up to 9 months prior to inclusion) * biologic dmards besides etanercept (up to 9 months prior to inclusion)